Needle and guide apparatus for passing suture

ABSTRACT

A trocar wound closure system includes a suture passing needle and a guide for directing the needle through the wound site. A distal portion of the needle includes a capture rod with a slot. An obturator tube with a cutout section can be axially actuated to align the cutout section with the slot, and then moved out of alignment so as to capture the suture. The guide includes at least two tracks for directing the needle through the tissue track. A suture catcher is located adjacent to the exit of each track and configured to be actuated from a radially extended configuration to a retracted configuration so as to capture the suture section inserted through each loop. Radially expandable arms at distal section are movable between an expanded configuration and a slender configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 15/485,075, filed Apr. 11, 2017, the disclosure ofwhich is incorporated by reference herein.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates to surgical instruments for approximation,ligation and fixation of tissue using a suture, and particularly to theapproximation of tissue separated by mean of an endosurgical trocarbeing inserted into a body cavity.

2. Description of Prior Art and Related Information

The following background information may present examples of specificaspects of the prior art (e.g., without limitation, approaches, facts,or common wisdom) that, while expected to be helpful to further educatethe reader as to additional aspects of the prior art, is not to beconstrued as limiting the present invention, or any embodiments thereof,to anything stated or implied therein or inferred thereupon.

Numerous methods currently exist for performing laparoscopic procedures.One of the more commonly used methods is known as closed laparoscopywhich utilizes a sharp needle (e.g., Veress needle) to puncture theabdominal wall and insufflate the abdominal cavity with an inert gassuch as carbon dioxide through the needle. This process of insufflatingthe cavity separates the abdominal wall from the underlying organscreating a gap for the surgeon to work within. A trocar/cannula systemis then used to maintain the insufflated cavity and provide a workingportal for which instruments can be passed into and out of the abdominalcavity to perform various surgical procedures. When the procedure iscompleted, it is desirable for the surgeon to close the incision siteusing suture material to minimize the risk of adverse post-operativeevents.

One of the post-operative complications associated with this procedureis the incidence of trocar site hernias, where a portion of an organ orfatty tissue protrudes out through the hole in the abdominal wallcreated by the trocar access portal. It is believed that improperclosure, or complete lack of closure, of the incision site at theperitoneum is the primary cause of these hernias which form during thepost-operative period ranging from several days to several monthsfollowing the procedure. Traditional methods of wound site close requirean additional set of instruments (suture passers, guides, etc.) to beintroduced into the surgery. A number of these instruments have beenpreviously disclosed. However, the prior art related to trocar woundsite closure instrumentation are typically cumbersome to use and do notprovide for a simple, reproducible, and reliable means of closing thewound site.

SUMMARY OF THE INVENTION

A preferred system according to the invention comprises a surgicalinstrument as well as a surgical instrument set that may have certainfunctions. First, the system may have the capabilities to provide entryinto the abdominal cavity and subsequently insufflating the cavity foruse in laparoscopic surgical procedures. In the preferred embodiment,the system comprises a needle apparatus having a sharp needle tip and aninsufflation channel to facilitate penetration into the abdominal cavityand insufflation. A unique obturator tip is provided to shield the sharpneedle tip upon insertion into the cavity.

Second, the system may have the capabilities to close the fascialperitoneal layer at the trocar wound site in a quick, consistent andreproducible manner at the end of the procedure. To facilitate closureof the wound, the system includes the same needle used in combinationwith a guide apparatus which has suture capture features disposed at ornear the distal tip.

The needle apparatus may also serve as a suture passer, in that it hasthe ability to carry and retrieve suture through tissue layers forsuturing closed the wound site. The needle apparatus also has theability to insufflate the abdomen during the laparoscopic procedure. Theneedle apparatus may comprise several components including: a handle,actuation mechanism, a connector for connecting the needle to a gasline, a capture rod, an outer needle shaft, and a spring loaded safetytip on a hollow obturator tube.

In a preferred embodiment, a handle at the proximal end of the needleapparatus allows for single-handed or double-handed use. The handle mayalso contain a finger loop or loops for additional security whileholding the needle. An actuator mechanism may be disposed adjacent tothe handle and configured for the deployment and retraction of thecapture rod used to secure the suture material within the tip of theneedle. The preferred actuator mechanism may include a sliding plungerthat translates along the long axis of the handle that moves the capturerod between a first position in an axially extended configuration and asecond position in an axially retracted configuration. The actuator maybe spring loaded in one direction such that the capture rod is biased tothe retracted position. This may allow the suture to be passivelycaptured without actuation of the plunger. The handle and actuator meansmay be constructed from metals (such as stainless steel, titanium oraluminum) or plastics (such as polyacetal, nylon, polypropylene,poly-ether-ether-ketone, or polycarbonate), or any combination of thetwo.

A long outer needle shaft may be connected to the proximal handle andextends distally over a length that may range from 2-38 centimeters, ormore preferably between 10-20 centimeters. The outer needle shaft mayhave a sharp tip, or needle peak, at the distalmost point to ease theinsertion of the needle through the various tissue layers. The outershaft may house an obturator tube that has a hollow, unobstructed innerlumen, with a blunt tip. The obturator tube may also house a capture rodused for securing the suture for passing through tissue. The outerneedle shaft, obturator tube and capture rod would optimally beconstructed from metals such as stainless steel, titanium or aluminum.

The distal-most end of the obturator tube may have a blunt or roundedplug or surface at the tip. The entire obturator tube may be springloaded to allow for the blunt tip to translate away from the tip of theneedle when it is loaded, and passively travel back to the tip of theneedle when it is unloaded. The obturator spring may be housed withinthe handle. The spring loaded obturator would serve as a safetymechanism for protecting the internal organs within the abdomen afterthe needle is passed through the abdominal wall.

A portion of the wall of the outer needle shaft may be cutout near thedistal tip which may be used to create a slot to accommodate the sutureduring the suture passing process. Similarly, a portion of the wall ofthe obturator tube may be cut out near the distal tip of the tube toprovide an opening for the capture rod to secure the suture to the wallof the outer needle shaft. The window cutout in the obturator tube mustbe long enough such that it can accommodate the suture as it travelsback and forth. Lastly, the capture rod has a slot with one or moreramped faces. A distal ramped surface on the capture rod slot is used tocapture the suture against the outer needle shaft. A proximal rampedsurface may assist in pushing the suture out of the window in theobturator tube, facilitating the release of the suture from the needle.

The needle capture rod is used to secure the suture to the needle forsuture passing activities. Initially the actuator may be pressed toextend the capture rod and expose the slot in the capture rod. A sectionof suture may be placed into the slot, and the actuator is released toretract the capture rod. As the capture rod retracts, the suture becomestrapped between the distal surface of the slot in the capture rod andthe cutout in the outer needle shaft. When the suture needs to bereleased, the actuator may be pressed again to extend the capture rod.As the capture rod is extended the proximal face of the slot may pushthe suture material out of the cutout in the obturator tube and awayfrom the needle shaft.

In another preferred embodiment, a luer connector or other quick connecttype device may be disposed on the proximal handle to provide an entrypassageway for the gas to enter into the needle. The unobstructed innerlumen of the obturator tube may allow for the passage of an inert gasfor insufflation of the abdomen.

The guide apparatus may serve dual purposes, as it first may be used toguide the needle through the abdominal wall in a repeatable manner, andsecond used to capture the suture material after it is passed into theabdominal wall. The guide may comprise a slotted barrel, collapsiblebarrel tip, plunger, main shaft, cap, suture catchers such as acapturing snare cord, and guide tubes along with various fasteners andsprings.

The slotted barrel may have two slotted channels to accommodate thepassage of the needle. The entries and exits of the two channels may bespaced 180 degrees radially apart from each other such that the stitchcan be placed on opposing sides of the wound. The channels' purpose isto guide the needle repeatably through the same tissue thickness andinto the suture snare cord, where the suture can be released. Thetrajectory of the channels is referenced off the inner wall of theperitoneum such that approximately 5-15 millimeters of tissue bite isachieved from the periphery of the wound. The proximal ends of thechannels may have a widened and or tapered opening to ease the entry ofthe needle into the channels. Slots in the channels will allow for themiddle section of the length of suture to be released from theconstraints of the guide channels. The width of the slots in thechannels should be large enough for the suture to easily be releasedfrom the channels, yet small enough to not allow the needle to exit thechannel or get caught against it.

The guide may comprise a main shaft that is slidably disposed within theslotted barrel of the guide. The main shaft may be used to actuate theexpanding arms, comprising living hinges in the preferred embodiment onthe collapsible barrel tip. One or more expanding arms may be used tolocate the guide against the inner peritoneal wall as a reference pointto ensure consistent tissue bite depth of the needle, as previouslydescribed. The main shaft may be spring loaded in a proximal positionsuch that the expanding arms are biased to a radially expanded positionwhere the outer profile of the arms exceeds the diameter of the slottedbarrel. As the main shaft moves distally, the arms may be contractedsuch that aligns their outer diameter with the outer diameter of theslotted barrel in a continuous slender fashion. The main shaft may beconnected at the distal end to the barrel tip and connected to theplunger on the proximal end.

The distal end of the barrel tip may have a blunt tip to minimize thepotential of harm or damage to the adjacent tissues during insertion.Moving proximally away from the blunt tip, the outer wall of the barreltip may have a tapered region that gradually radially increases to theouter profile of the guide as designated by the outer diameter of theslotted barrel. The tapered section may facilitate the ease of insertionof the guide into the trocar wound site.

The barrel tip may have one or more stop tabs that provide a hard stopfor the barrel tip as the expanding arms are actuated, to preventexcessive flexion in the hinge material. Along the length of the stoptabs, a cutout section may exist for the suture catcher, such as snareloop, to be retracted into for capturing the suture material against theguide.

The guide may have a slider that is used to actuate the snare cordmaterial. The slider may be slidably disposed on the slotted barrel. Twosuture catchers, such as snare cords, may be connected at their ends tothe slider body, with a loop formed at the distal tip of the guide. Theslider may be spring loaded such that the snare cords are biased into aradially extended position. As the slider is pulled proximally, thesnare cord is retracted against the extension arms of the barrel tip. Asthe slider is released distally, the snare cord is radially extended outand away from the barrel to create two snare loops for the suture to bepassed into. The slider may have two tabs that can be used to pull theslider proximally using one or more fingers on each tab. The snare cordsmay be constructed from a mono- or multi-filament wire that has theflexibility to easily bend and conform to various geometries yet stiffenough to create a self-supported snare loop that extends generallyperpendicular to the long axis of the guide. Materials that may be usedto construct the snare cord include plastics such as nylon,polyethylene, polyester or polypropylene or metals such as stainlesssteel or nitinol.

A plunger at the proximal end of the guide may be used to provide acounterforce when pulling on the slider. As the plunger is pushed andthe slider is simultaneously pulled, the snares will move into theretracted position first, and then the expanding arms are retracted intothe slender configuration. As the slider is released, the spring forceswill extend the snares to the extended position and the expanding armswill be converted to the radially expanded condition.

In another embodiment, the snares may include a basket element toprevent the needle from traversing deeply into the abdominal cavity andcausing potential harm.

The basic procedural steps of the utilization of the suturing system mayflow as follows. At the end of the surgical procedure, the trocar isremoved from the body exposing the wound. The slider on the guide ispulled up against the plunger to contract the flexing arms and retractthe snares such that the profile of the guide is at its minimum. Theguide can then be inserted into the wound with the plunger continuallypulled against the slider. The slider and plunger are then releasedexpanding the arms and deploying the snares. The guide can be pulledupward and away from the body cavity until the arms rest against theinner wall of the peritoneum. A short tail at one end of the suture issecured by the capture rod in the tip of the needle. The needle, withsuture, is then passed through a first needle channel in the guide andis advanced through the guide, tissue and snare, into the abdominalcavity. The needle then releases the suture into the cavity and isretracted from the body. A second short tail at the second free end ofthe suture is then secured by the capture rod in the needle. The needle,with suture, is then passed through the second needle channel in theguide and advanced through the guide, tissue and snare, into theabdominal cavity. The needle then releases the suture into the abdominalcavity and removed from the guide and body. The remaining loop of sutureoutside the body may then be released from each of the slots in theneedle tracks. The slider on the guide is then again pulled against theplunger to retract the snares, capturing the free ends of suture, andcontract the flexing arms allowing the guide to be removed from thewound, carrying the suture with it. Once outside the body, the snaresmay need to be deployed enough to release the free ends of the suture.Lastly, a knot may be tied and pushed down into the wound to close thetrocar puncture site.

In an alternative procedure, the guide may be used to place a FIG. 8stitch using two separate sutures rather than a single stitch using onlyone suture. The guide is initially inserted into the wound as previouslydescribed. A short tail at a first end of a first suture is loaded intothe needle, passed through the first channel of the guide, and releasedinto the abdominal cavity. At this point a short tail at the second endof the first suture is loaded into the needle and passed through thesecond channel. The guide may then be rotated approximately 90 degreesfrom the initial orientation of the first suture passing. A short tailat one end of a second suture may be loaded into the needle, passedthrough the first channel of the guide, and released into the abdominalcavity. The needle is retracted and then a tail from the opposing end ofthe second suture is loaded and passed through the second channel of theguide and released into the abdominal cavity. The slider is pulled, andthe guide is removed from the wound with all four ends of suturecaptured in the snares. Knots may then be tied in each of the individualsutures to close the wound.

The basic procedural steps for abdominal entry and insufflation of thecavity may flow as follows. The needle is used to enter the abdominalcavity using standard closed laparoscopic techniques. A gas line isconnected to the handle allow for an inert gas to be passed into theabdominal cavity. The inert gas is then turned on until the cavityreaches an appropriate level of insufflation to allow for the procedureto be performed with appropriate visualization. The needle is thenremoved, and a trocar is inserted into the puncture site to perform theprocedure.

In an alternative embodiment, the guide may comprise a monolithic snarewhere the actuator section, shaft section and suture catchers, such assnare loops, are all integrally formed. The barrel may comprise two halfbarrel pieces that can be secured together.

The barrel defines an inner lumen and at least two diagonal channels incommunication with two corresponding window openings adjacent to adistal end of the barrel. Each channel comprises a wider proximalopening that tapers towards a distal exit so as to serve as a fulcrumfor the needle apparatus directed therethrough. Each snare loopcomprises a tip that may serve as a landmark indicator to position theguide against the internal peritoneal wall.

The snare loops can be completely retracted within the barrel by movingthe actuator section and integral shaft section of the snare axially andproximally through the inner lumen. The enlarged tip of each snare loopcomprises a positive stop abutting the narrower window opening withinthe barrel so as to prevent excess travel of the monolithic snare withinthe barrel.

The guide may comprise indicia on an outer barrel surface to indicatehow far to insert

the barrel into the abdomen (i.e., until the mark is no longer visible)so as to achieve a more optimal “bite,” namely, the horizontal distancefrom the puncture location of the needle through the peritoneum to theclosest edge of the defect coinciding with the sidewall of the barrel.

An alternative method is provided to achieve a desirable placement ofthe needle and suture through the tissue, particularly for thinnerabdominal walls. Prior to the placing the needle though the tissue, thelateral tip of a snare loop may be used as a landmark while tilting theguide at an angle to the primary guide axis, until the first lateral tipcomes in close proximity to or abuts the peritoneum. The tissue areawill compress, and placement of the needle will encompass a greateramount of tissue.

With the tilted guide in position, the suture engaging device, with afirst free end section of suture engaged, may be inserted through afirst channel while carrying the first section of suture. Once theneedle exits the channel it passes through the compressed layers oftissue and enters the body cavity. As it enters the body cavity, theneedle passes through the first suture catcher, which may comprise asnare loop. The needle may release the strand of suture and be removedfrom the body leaving the suture section loosely inside the expandedsnare loop. Thus, the suture section is carried into the body cavity toa point where the suture section intersects and traverses the generallyplanar opening defined by the expanded snare loop.

The guide is then tilted in the opposite direction, such that theopposite second lateral tip of the second suture catcher, such a secondsnare loop, comes in close proximity to the peritoneum. With the tiltedguide in position, the second free end section of suture may then beengaged by the suture engaging device and inserted through the opposingsecond channel to place the second end suture section. Once the needleexits the opposing channel it passes through the compressed layers oftissue and enters the body cavity. As it enters the body cavity, theneedle passes through the opposing second suture catcher, e.g., snareloop. The needle may release the strand of suture and be removed fromthe body leaving the suture sections within the boundaries of therespective snare loops.

Moving the actuator section away from the barrel retracts the snareloops so as to capture the suture sections 542, 543. With both suturesections 542, 543 captured, the guide 530 is retracted from the tissuetrack, carrying the suture sections 542, 543. With the guide 530 andsuture sections 542, 543 exposed outside the body cavity, the actuatorsection 533 can be pushed toward the barrel 531 extending the suturesnare loops 534, and thus releasing the suture sections 542, 543. A knotcan then be tied in the suture sections 542, 543 and secured to provideclosure of the wound.

Embodiments of the present invention provide a surgical guide device tobe placed through a tissue track comprising a barrel defining a firstchannel and a second channel, the first channel comprising a first exitfor directing a first suture portion into a body cavity, the secondchannel comprising a second exit for directing a second suture portioninto the body cavity; a distal tip located distally to the barrel andcomprising a distal tip wall; a first self-supporting suture catcherpositioned adjacent to the first exit; a second self-supporting suturecatcher positioned adjacent to the second exit; and an actuator coupledto the first and second suture catchers, the actuator being configuredto move the first and second suture catchers in unison between aradially extended configuration and a retracted configuration, wherein,in the radially extended configuration, the first self-supporting suturecatcher defines a first unencumbered opening through which the firstsuture portion intersects the opening and then resides loosely withinthe first opening, wherein in the radially extended configuration, thesecond self-supporting suture catcher defines a second unencumberedopening through which the second suture portion intersects the openingand then resides loosely within the second opening; the first and secondself-supporting suture catchers are apart from one another; and thefirst self-supporting suture catcher and the second self-supportingsuture catcher extend radially outward and in opposite directions fromthe distal tip.

Embodiments of the present invention further provide a surgical guidedevice to be placed through a tissue track comprising a barrel defininga first channel and a second channel, the first channel comprising afirst exit for directing a first suture portion into a body cavity, thesecond channel comprising a second exit for directing a second sutureportion into the body cavity; a distal tip located distally to thebarrel and comprising a distal tip wall; a first self-supporting suturecatcher positioned adjacent to the first exit; a second self-supportingsuture catcher positioned adjacent to the second exit; and an actuatorcoupled to the first and second suture catchers, the actuator beingconfigured to move the first and second suture catchers in unisonbetween a radially extended configuration and a retracted configuration,wherein in the radially extend configuration, the first self-supportingsuture catcher defines a first opening through which the first sutureportion resides loosely upon release; in the radially extendedconfiguration, the second self-supporting suture catcher defines asecond opening through which the second suture portion resides loosely;in the radially extended configuration, when the surgical guide deviceis positioned through the tissue track, the body cavity on a first sideof the barrel has the first self-supporting suture catcher and the bodycavity on a second side of the barrel has the second self-supportingsuture catcher; retraction of the first and second self-supportingsuture catchers in unison simultaneously captures the first and secondsuture portions by trapping the first and second suture portions withoutrotating the first and second self-supporting suture catchers; the firstand second self-supporting suture catchers are apart from each other;and the first self-supporting suture catcher and the secondself-supporting suture catcher extend radially outward and in oppositedirections from the distal tip.

Embodiments of the present invention also provide a surgical guidedevice to be placed through a tissue track comprising a needle forpassing suture; a barrel defining a first channel and a second channel,the first channel comprising a first exit for directing a first sutureportion into a body cavity, the second channel comprising a second exitfor directing a second suture portion into the body cavity; a firstself-supporting suture catcher positioned adjacent to the first exit; asecond self-supporting suture catcher positioned adjacent to the secondexit; a distal tip located distally to the barrel and comprising adistal tip wall; and an actuator coupled to the first and second suturecatchers, where the first and second suture catchers extend from theactuator, the actuator being configured to move the first and secondsuture catchers in unison between a radially extended configuration anda retracted configuration, wherein, in the radially extendedconfiguration, the first self-supporting suture catcher defines a firstopening, wherein in the radially extended configuration, the secondself-supporting suture catcher defines a second opening through whichthe second suture portion resides loosely within the second opening; thefirst and second self-supporting suture catchers are apart from eachother; and the first self-supporting suture catcher and the secondself-supporting suture catcher exit radially outward and in oppositedirections from the distal tip.

These and other features, aspects and advantages of the presentinvention will become better understood with reference to the followingdrawings, description and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the present invention are illustrated as an exampleand are not limited by the figures of the accompanying drawings, inwhich like references may indicate similar elements.

FIG. 1 illustrates an oblique view of a preferred embodiment of aneedle;

FIG. 2 illustrates a perspective side view of a proximal end of theneedle;

FIG. 3 illustrates a perspective side view of a distal end of theneedle;

FIG. 4A illustrates a perspective side view of a strand of suture beingloaded into the needle with an extended capture rod;

FIG. 4B illustrates a perspective side view of a strand of suturecaptured by the needle after retraction of the capture rod;

FIG. 5A illustrates a cross-sectional view of the needle demonstratingthe internal components;

FIG. 5B illustrates a cross-sectional view of the needle demonstratingthe inner workings of a needle handle;

FIG. 6A illustrates an oblique view of the guide with radially expandedarms and suture catchers;

FIG. 6B illustrates an oblique view of the guide with radially expandedarms and contracted suture catchers;

FIG. 6C illustrates an oblique view of the guide with radiallycontracted arms and suture catchers;

FIG. 7 illustrates an oblique view of the distal tip of the guide withradially expanded arms and suture catchers;

FIG. 8 illustrates an oblique view of the guide reveals pathways forsuture passing;

FIG. 9A illustrates a cross-sectional view of the guide showing internalcomponents;

FIG. 9B illustrates an enlarged cross-sectional view of the guideshowing distal internal components;

FIG. 9C illustrates an enlarged cross-sectional view of the guideshowing proximal internal components;

FIG. 10A illustrates an exploded view of barrel tip components;

FIG. 10B illustrates an isometric view of barrel tip components;

FIG. 11 illustrates a perspective side view of the insertion of guideinto tissue;

FIG. 12 illustrates a perspective side view of the insertion of theneedle with first end of suture strand into the guide;

FIG. 13A illustrates a perspective side view of the insertion of theneedle with second end of suture strand into the guide;

FIG. 13B illustrates a perspective side view of an enlarged view of theinsertion of the needle with second end of suture strand into the guide;

FIG. 13C illustrates a perspective side view of the guide with thesuture catchers retracted so as to capture the suture sections;

FIG. 13D illustrates a perspective side view of the guide retracted outfrom the tissue track with the captured suture sections;

FIG. 14 illustrates an isometric view of snare with protective basket;

FIG. 15 illustrates a preferred method for closing a surgical wound witha single stitch using a system comprising preferred embodiments of aguide and a suture engaging device disclosed above;

FIG. 16 illustrates a preferred method for closing a surgical wound witha figure eight stitch using the preferred system disclosed above;

FIG. 17 illustrates a preferred method for creating pneumoperitoneum forlaparoscopic procedures using an insufflation needle;

FIG. 18 illustrates an isometric view of the guide and suture engagingdevice;

FIG. 19A illustrates an exploded view of the guide;

FIG. 19B illustrates an isometric view of the guide;

FIG. 20A illustrates a detailed view of the proximal end of the guide;

FIG. 20B illustrates an isometric view of the guide with variouspositions of the suture engaging device;

FIG. 21A illustrates an isometric view of the guide with the snareretracted;

FIG. 21B illustrates a detail view of the distal end of the guide withthe snare retracted;

FIG. 22A illustrates a front view of the guide with snares extended;

FIG. 22B illustrates a planar view of the suture catchers;

FIG. 23 illustrates a detailed view of the proximal end of the guide;

FIG. 24 illustrates an isometric view of the guide and suture engagingdevice;

FIG. 25A illustrates front view of the guide and needle placed in thewound;

FIG. 25B illustrates detail view of the guide and needle placed in thewound;

FIG. 26 illustrates front view of the guide and needle placed in thewound with the needle piercing the skin;

FIG. 27A illustrates front view of the guide and needle placed deeper inthe wound;

FIG. 27B illustrates detail view of the guide and needle placed deeperin the wound;

FIG. 28A illustrates isometric view of the guide placed deeper in thewound;

FIG. 28B illustrates detail view of the guide with the line markpositioned in the wound;

FIG. 28C illustrates detail view of the guide with the lateral tippositioned in the wound;

FIG. 29 illustrates isometric view of the guide and suture engagingdevice in the wound where the guide is tilted;

FIG. 30 illustrates an alternative method for closing a surgical woundwith suture using a system comprising preferred embodiments of a sutureengaging device and a guide having a monolithic snare;

FIG. 31 illustrates isometric view of the guide with a recess feature;and

FIG. 32 illustrates a detail view of the recess feature.

Unless otherwise indicated illustrations in the figures are notnecessarily drawn to scale.

The invention and its various embodiments can now be better understoodby turning to the following detailed description wherein illustratedembodiments are described. It is to be expressly understood that theillustrated embodiments are set forth as examples and not by way oflimitations on the invention as ultimately defined in the claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OFINVENTION

In a preferred embodiment, a system is provided for closing trocar woundsites. The system comprises a suture engagement device and a guide todirect the device through the body tissues.

An improved needle and guide instrument set is further described belowas it allows for the surgical placement of suture to be completed“blind,” namely, without the aid of an endoscope for directvisualization of the abdominal cavity. This may be advantageous incertain surgical procedures where an endoscope is not being used or doesnot provide adequate visualization of the surgical site.

A preferred embodiment of a suture engagement device or suture passingneedle, or simply needle, 100 is shown in FIG. 1. The needle 100 maysimply have a handle 101 and actuator 105 at the proximal end 12. Anouter tube 108 is connected to the handle 101 that terminates with asuture capture mechanism 107, sharp needle tip 109, and spring loadedsafety tip 112 at the distal end 14 of the needle 100, as shown in FIG.3.

FIG. 2 illustrates a closer view of the proximal portion 16 of theneedle 100. The base of the proximal end 12 of the needle 100 is a mainhandle or housing 101. The handle 101 may have a finger loop 102 thatmay accommodate one or more fingers, as well as a series of one or moregrooves 103 to accommodate the placement of additional fingers. Thefinger loop 102 and grooves 103 may provide the user with a comfortable,secure grip of the device and provide greater control when handling thedevice 100. Slidably disposed within the housing 101 is an actuator 105that may be used to control a suture capture mechanism 107 at the distaltip of the needle 101. At the proximal end of the actuator 105, anenlarged surface 106 may provide an ergonomic location for a thumb orother finger to trigger the actuator 105. The length travel of theactuator 105 may be constrained by a pin 123 that connects to theactuator 105 and slides within a slot 104 on the handle 101. The pin 123also serves the purpose of rotationally constraining the actuator 105.

FIG. 3 illustrates a closer view of the distal portion 18 of the needle100. An obturator tube 111 may be slidably disposed within an outer tube108, and a capture rod 114 may be slidably disposed within the obturatortube 111. The outer tube 108 terminates at a sharp tip 109 that may havetwo or more beveled edges 118 to facilitate the ease of passage of theneedle 100 through tissue. The obturator tube 111 has a blunt surface112 at its distal end 20 and may be used to serve as a safety tip forthe needle 100. The obturator tube 111 may be spring loaded such that itcan passively travel between an axially extended and retracted position.Initially, the obturator tube 111 may be biased in the extended positionwhere the blunt surface 112 extends further distally than the sharp tip109 of the outer tube 108. As the distal tip of the needle 100 is pushedinto the tissue with enough load to overcome the force of the spring,the obturator tube 111 may retract proximally, ultimately exposing thesharp tip 109 of the outer tube 108. The sharp tip 109 and edges 118 maythen minimize the trauma to the tissue layers as the needle 100 isinserted. Once the tip 109 of the needle 100 enters the body cavity, theobturator tube 111 may passively return to the distally extendedposition shielding the sharp tip 109 from inadvertently damaging thetissue structures within the body cavity.

The purpose of the capture rod 114 is to secure the suture to the needle100, in a manner further described below.

In FIGS. 4A and 4B, the suture capture mechanism 107 at the distal end14 of the needle 100 preferably comprises a channel 110 in the outertube 108, a cutout section 113 of the obturator tube Ill, and a slot 115in a capture rod 114. The suture capture mechanism 107 may functionthrough the movement of the capture rod 114 between an axially extendedand retracted position that is controlled by the actuator 105 at theproximal end 12 of the needle 100. In FIG. 4A, the capture rod 114 isshown in the extended position such that a strand of suture 125 can beplaced through the cutout 113 in the obturator III and into the slot 115of the capture rod 114. In this axially extended position, the obturatorcutout 113 is open to, and aligned with, the capture rod slot 115 inorder to receive the suture 125. In FIG. 4B, the capture rod 114 isshown in the axially retracted position such that the strand of suture125 is secured between the channel 110 of the outer tube 108 and thedistal face 117 of the slot 155 in the capture rod 114. When the suture125 needs to be released, the actuator 105 returns the capture rod 114to the extended position. A proximal face 116 of the capture rod 114,shown in FIG. 4A, may aid in pushing the suture 125 out of the obturatorcutout 113 and away from the outer profile of the outer tube 108.

Cross sectional views of the preferred embodiment of the needle 100 areshown in FIGS. 5A and 5B that illustrate the inner workings of thehandle 101. A proximal portion 22 of the obturator tube III may beconnected to an obturator hub 119. The hub 119 may have one or morerotational alignment structures such as a flat face 120 or an alignmentpost 121 that prevent the hub 119 from rotating about a long axis 24 asit translates back and forth. Additional extrusions 128 inside thehousing 101 may be necessary to mate with the alignment protrusions 120,121 on the hub 119. The alignment of the hub 119 is critical to ensurethe cutout 113 at the distal end maintains its alignment for suturecapturing. The hub 119 may also have a cylindrical portion 126 toaccommodate a coil spring 122 that is used to spring load the obturatortube Ill. The opposing end of the spring 122 may connect to the actuator105 at a similarly accommodating cylindrical portion 127. The capturerod 114 may be attached to the actuator 105 with a pin 123 that passesthrough a hole 124 in the actuator and a slot 129 in the capture rod. Aspreviously described, the pin 123 may slide within a window 104 of thehousing 101 that is used to limit the travel and prevent rotation of thecapture rod 114.

In FIGS. 6A-6C, a preferred embodiment of a guide 130 may be useful fordirecting the above described suture engaging device through a bodywall. The guide 130 may be particularly useful for the placement ofsutures used in closing wounds or openings through body walls made insurgical procedures to access internal body cavities. Accordingly, theguide 130 preferably comprises two pathways diagonal to each other andoriented to direct a needle apparatus to both a first internal locationto carry and release a first end of a suture, and a second internallocation to carry and release a second end of a suture.

An oblique view of the preferred guide 130 is shown in FIGS. 6A-6C. Theguide 130 may comprise a distal barrel tip 140 with two radiallyexpanding arms 147, two suture capturing mechanisms, or suture catchers,which may comprise snare loops 146 in this illustrated embodiment, amain barrel 131 with two channels 132, 136 (shown in FIG. 8), a plunger153, and a slider 156. The two channels 132, 136 are disposed within themain barrel 131 to guide the suture passing needle 100 through thetissue to be sutured, as shown in FIGS. 8 and 12. The slider 156 may beslidably disposed onto the main barrel 131 to provide actuation of thesuture snare loops 146. The plunger 153 may be slidably disposed ontothe main barrel 131 to provide actuation of the expanding arms 147. Theexpanding arms 147 may serve as an internal cavity securing mechanism,which is used to secure the guide 130 against the internal peritonealwall. The two suture snare loops 146 serve the purpose of capturing thesuture material after it has been passed through the tissue wall. Theslider 156 may facilitate the ease of handling of the guide 130.

As the slider 156 translates with respect to the barrel 131, the suturesnare loops 146 move between two positions of radially extended shown inFIG. 6A and retracted shown in FIG. 6B. When each snare 146 is in theradially extended configuration, a loop, ring, circle or hoop shape ispreferably formed. The snare loop 146 provides a region for a suturepassing needle to pass into and drop off the suture. The snare loop 146defines an opening through which the carried suture traverses. When thecarried suture is released from the suture engaging device, the suturesection intersecting the opening of the snare loop 146 resides looselyuntil the snare loop 146 is retracted. When the snare loop 146 isretracted, the suture material becomes trapped between the snare loop146 and the wall of the distal barrel tip 140.

Further, as the plunger 153 translates with respect to the barrel 131,the radially expanding arms 147 at the distal barrel tip 140 movebetween two positions of radially expanded, or flared out, as shown inFIG. 6B, and radially contracted, or slender, as shown in FIG. 6C. Eachof the expanding arms 147 preferably comprise a living hinge section,where the material is cut thin at specific locations allowing for thematerial to flex. It is to be expressly understood that the expandingarms may comprise a variety of structures and mechanisms that arecapable of moving between slender and flared out configurations.

As shown in FIG. 7, radially adjacent to the expanding arms 147 may beone or more distally extending stop tabs 143. The stop tabs 143 areconfigured to provide a mechanical stop for the distal end cap 141 ofthe barrel tip 140 to collide against preventing excessive flex withinthe thin sections 148, 149, 150 of the expanding arms 147. The stop tabs143 may also have a slot 145 cutout in the outer wall that provide aregion for the snare loop material 146 to be housed when the snare loop146 is in the retracted state. When a section of suture 159 is capturedwithin the snare loop 146, the slot 145 may provide additional securityto the captured suture 159, as opposed to the snare loop 146 pulling thesuture against a smooth surface.

The barrel tip 140 may comprise a separate component that is assembledto the main barrel 131. Two tabs 166 on the main barrel 131 may beplaced radially opposite to each other. Slots 167 in the barrel tip 140may allow for the tip 140 to initially slide past the tabs 166 on themain barrel 131. The slots 167 may have an undercut section 168 that maybe engaged by rotating the tip 140 and pulling it distally. The gap thatis created between the tip 140 and the barrel 131 may be filled with adeformable c-shaped clip 169 to prevent the tip 140 from dislodging fromthe barrel 131.

The slider 156 is slidably disposed on the main barrel 131 as it cantravel between a distal position shown in FIG. 6A and a proximalposition shown in FIG. 6B. Two finger tabs 154 are preferably disposednear the distal end of the slider 156 and configured to be grasped withone or more fingers. The thumb or palm of the hand may then be pressedagainst the proximal face 157 of the plunger 153. The finger tabs 154may then be pulled proximally to actuate the guide 130 with the plunger153 being used to provide a counterforce. The slider 156 can reach astop, achieved by either an internal feature of the slider 156 engagingthe main barrel 131 or the snare loops 146 being fully retracted.Additional force between the slider 156 and the plunger 153 may overcomethe counterforce translated to the plunger 153 by a spring. The plunger153 can then move axially to actuate the expanding arms 147 to theslender contracted state. Upon release of the force between the slider156 and the plunger 153, the plunger 153 can return to the originalposition and result in the expanding arms 147 reverting to the radiallyexpanded position. The slider 156 may be biased to the distal positionby a spring that passively returns the slider 156 to the distal positionwhen released, thus resulting in the suture loops 146 reverting back tothe radially extended position. It may be appreciated that biasing theguide 130 in this configuration may allow for the surgeon to have hishands free from operating the guide 130 such that work with otherinstruments may be conducted once the guide 130 has been inserted intothe trocar wound.

In the preferred embodiment, the guide 130 provides two different,diagonal pathways for a suture passing needle apparatus and thuscomprises first and second channels 132, 136 as more clearly shown inFIG. 8. The channels 132, 136 are directionally diagonal to the longaxis “24” of the guide 130 at some acute angle, preferably in the rangeof 5-30 degrees. The angle of the channels 132, 136 controls the depthof bite into the tissue, such that a greater angle provides a greaterbite of tissue. Angular spacing between entries to the channels 132, 136are preferably equal (i.e., equiangular) depending upon the number ofchannels, e.g., 180 degrees apart if there are two channels, 120 degreesapart if there are three channels, etc. Two separate entry points 133,137 are provided on the channels 132, 136 for a suture passing needle toenter the guide 130, as well as two separate exit points 134, 138. Eachchannel 132, 136 has a slot 135, 139, or opening that allows for astrand of suture to be removed from the channel. This may be necessaryto complete the suture loop in the tissue.

The internal workings of the guide 130 are shown in FIGS. 9A-9C, whichillustrate cross-sectional views through the center of the guide 130. Aninner shaft 158 spans from the proximal end 30 to the distal end 32 ofthe guide 130 and is used to actuate the expanding arms 147. The shaft158 connects at the distal end 32 of the guide 130 to the distal end cap141 of the barrel tip 140 and connects at the proximal end 30 of theguide 130 to the plunger 153. A retaining ring, heat stake, or othermechanical fastening means may be used to secure the shaft 158 to theplunger 153. When the slider 156 is pulled into the proximal position asshown in FIG. 6B, a counterforce is applied to the plunger 153. Upon theslider 156 reaching the full proximal extension, further pushing on theplunger 153 advances the shaft 158 distally which in turn advances theend cap 141 on the barrel tip 140 distally, causing the expanding arms147 to radially contract as shown in FIG. 6C. Upon release of theplunger 153 and slider 156, the shaft 158 may passively return to itsnative proximal position, pulling the end cap 141 with it and causingthe expanding arms 147 to radially extend.

Two springs are used to bias the guide 130 into the configurations shownin FIGS. 6A and 9A, with the radially extended arms 147 and snare loop146 expanded, and the plunger 153 in the proximal position. A sliderspring 155 is used to bias the slider 156 to the proximal position. InFIG. 9C, one end of the slider spring 155 is captured at the proximalend 40 of the main barrel 131 by two spring capture tabs 173. Theopposing end of the spring 155 rests against an inner edge 174 of theslider 156, forcing the slider 156 to a proximal position. In FIG. 9B, aplunger spring 165 is used to bias the distal barrel tip 140 in theproximal position. The spring 165 is captured between inner shaft 158and the proximal face of track support 170 connected to the barrel tip140. This plunger spring 165 forces the inner shaft 158 and plunger 153in a proximal position, pulling the barrel tip 140 proximally as well.

In FIG. 9C, the free ends of a snare cord loop 146 may be captured in aretaining cap 175 that is fixed to the proximal end of the slider 156.The snare cord 146 may traverse distally down the guide 130 eitherthrough snare channels 176 inside the main barrel 131 or guide tubes 171that span through a portion of the length of the main barrel 131.

The snare channels 176 or guide tubes 171 may be used to constrain thesnare cord material 146 and prevent it from bunching up or bucklingunder load as it travels proximally and distally within the guide 130.

FIGS. 10A-10B illustrate the laminate component construct that providestracks 172 within the barrel tip 140. The track support 170 ispositioned between two track side panels 177. The tracks 172 may be usedto guide the snare cord 146 from a position within the barrel tip 140,parallel to the long axis of the guide 130 to a position exiting thebarrel tip 140 relatively perpendicular to a long axis 42 of the guide130. These curved exit tracks 172 may take on an angulation ofapproximately 90 degrees, however this angle may be made more acute orobtuse to optimize the positioning of the snare.

In the case of a laparoscopic surgery involving use of a trocar, theguide 130 may be placed through the tissue layers of the open trocarwound site as shown in FIG. 11. This tissue track may consist of skin160, adipose tissue 161, muscle and fascia 162 and the peritoneum 163.Prior to insertion of the guide 130 through the tissue track, the slider156 and plunger 153 may be pulled into the compressed position to placethe arms 147 in the slender configuration, and the snare loops 146 inthe retracted position. Once the distal barrel tip 140 of the guide 130is appropriately placed posterior to the peritoneal layer 163, theslider 156 and plunger 153 may be released and spring-biased to the openposition, extending the suture snare loops 146 and expanding the tissueengaging arms 147. The guide 130 may then be retracted until the tissueengaging arms 147 are resting against the inner peritoneal wall 163 toalign the channels 132, 136 with the appropriate layers of tissue to besutured.

Once the guide 130 is secured against the peritoneal wall 163, thesuture engaging device 100, with a first free end section 44 of suture125 engaged, may be inserted through a channel 132 while carrying thesection 44 of suture 125, as shown in FIG. 12. Once the needle 100 exitsthe channel 132 it passes through various layers of tissue 162, 163 andenters the body cavity. As it enters the body cavity, the needle 100passes through the snare loop 146. The needle 100 may release the strandof suture 125 and be removed from the body leaving the suture section 44loosely inside the expanded snare loop 146. Thus, the suture section 44is carried into the body cavity to a point where the suture section 44intersects and traverses the generally planar opening 48 (see FIG. 11)defined by the expanded snare loop 46.

The second free end section 46 of suture 125 may then be engaged by thesuture engaging device 100 and inserted through the opposing channel 136to place the second end suture section 46. As shown in FIGS. 13A-13B,once the needle 100 exits the channel 136 it passes through variouslayers of tissue 162, 163 and enters the body cavity. As it enters thebody cavity, the needle 100 passes through the opposing snare loop 146.The needle 100 may release the strand of suture 125 and be removed fromthe body leaving the suture sections 44,46 within the boundaries of therespective snare loops 146.

FIG. 13C shows the snare loops 146 retracted so as to capture the suturesections 44, 46, which is the configuration actuated in FIG. 6B when theslider 156 is moved proximally with respect to the main barrel 131. Withboth suture sections 44, 46 captured, the guide 130 is ready to beretracted from the tissue track 50, carrying the suture sections 44,46as shown in FIG. 13D.

FIG. 14 illustrates an alternative embodiment including a pouch, orbasket, 178 secured to the snare. The pouch 178 is positioned below thesnare and comprises a floor 180 as a protective element to prevent thedistal tip of the needle 100 from extending deeper into the abdominalcavity. The pouch may be constructed of a compliant fabric, rigidpolymer, or other such material to obstruct needle penetration.

In FIG. 15 a preferred method 200 is disclosed for closing a surgicalwound using a surgical instrumentation system comprising a guide andsuture engagement device as described above. It will be appreciated thatthis method 200 enables an operator to pass and retrieve the sutureusing simply a guide and suture engaging device without the need foradditional instrumentation or visualization inside the body cavity. Theinitial step 201 comprises actuation of the guide into a slenderconfiguration and insertion of the distal tip into the surgical wound.In step 202, a securing mechanism, which may comprise living hinges, isradially expanded for engagement with the inner body cavity wall whenthe guide is retracted, preventing the guide from being pulled out ofthe wound as well as providing a reference point for the sutureplacement. Step 203 comprises the deployment of two suture catchers,which may preferably comprise snare loops, to be used to capture thesuture material. It can be appreciated that step 202 and 203 may becombined such that they occur simultaneously. It will further beappreciated that steps 202 and 203 may occur by default (e.g., throughuse of springs) upon release of the guide such that the operator mayhave both hands free to engage other instruments.

Step 204 comprises engaging and capturing a first section of a suturewith a suture capture mechanism disposed at the distal end of a sutureengaging device having a shaft.

In step 205 the suture engaging device with secured suture is insertedthrough a first track of the guide, through various tissue layers, andultimately ending inside the body cavity as it passes through the firstsnare loop. Step 206 comprises releasing the first suture section fromthe suture engaging device and retracting the device from the body andguide. The first section of the suture may remain inside the body cavityand loosely encapsulated within the boundaries of the expanded firstsnare loop.

Step 207 comprises engaging and capturing a second section of the samesuture with the suture capture feature on the suture engaging device. Instep 208, the suture engaging device with secured suture is insertedthrough a second track of the guide, through various tissue layers,ending inside the body cavity as it passes through the second snareloop. Step 209 comprises releasing the suture from the suture engagingdevice and retracting the device from the body and guide while leavingthe second section of the suture inside the body cavity and looselyencapsulated within the boundaries of the second snare loop.

In step 210, the suture material may be passed through the slots in thechannels on the guide to release the suture from the constraint of thechannel. Step 210 comprises retracting the snare loops back against theguide and securing the suture between the outer guide wall and the snareloop. In step 211, the guide may be actuated such that the securingmechanism is radially contracted and converting the guide into theslender configuration. It can be appreciated that step 210 and 211 maybe combined such that they occur simultaneously or seamlessly with asingle motion. In step 213 the guide can be removed from the body cavitywith the two captured sections of the suture. Step 214 comprisesreleasing the suture from the snare loops on the guide. The proceduremay then be completed at step 215 by forming a single stitch loop toclose the surgical wound.

In FIG. 16 an alternative method 300 is illustrated for closing asurgical wound using a surgical instrumentation system by forming afigure eight stitch as opposed to the single stitch method 200. In step301 a first length of suture is passed into the body at a first locationof the wound comprising the same steps 201-210 as previously described.In step 302, the guide is rotated 90 degrees from the initial positionin step 301. In step 303, a second length of suture is passed into thewound at a second location of the wound comprising steps 202-214. Step304 comprises completing the closing of the wound by forming a stitchloop with each of the suture strands.

In FIG. 17 a preferred method 400 is illustrated for creatingpneumoperitoneum for laparoscopic procedures using an insufflationneedle. Step 401 comprises inserting the tip of the needle through theabdominal wall and into a body cavity. This step may also initiallyrequire a small incision in the skin to be made prior to insertion ofthe needle.

In step 402, a gas line may be connected to the needle. Step 403comprises pumping an inert gas through the needle and into the bodycavity until an appropriate internal pressure is achieved. Lastly, instep 404 the needle may be removed from the body and the endoscopicprocedure can begin.

In FIG. 18, an alternative embodiment of a guide 502 may be useful fordirecting a suture engaging device 501 through a body wall. The guide502 may be particularly useful for the placement of sutures used inclosing wounds or openings through body walls made in surgicalprocedures to access internal body cavities. Accordingly, the guide 502preferably comprises two pathways diagonal to each other and oriented todirect a needle apparatus to both a first internal location to carry andrelease a first end of a suture, and a second internal location to carryand release a second end of a suture. The guide 502 comprises a proximalend 581 and a distal end 582.

An oblique view of the preferred guide 502 is shown in FIGS. 19A-19B.The guide 502 may comprise a monolithic snare, or suture capturingmechanism, 504. The suture capturing mechanism may comprise two suturecatchers 507. In a preferred embodiment, each suture catcher 507 maycomprise a self-supporting snare loop 507.

The guide 502 further comprises a shaft section 506, and an actuatorsection 505, all integrally formed. A barrel 503 comprises two channels509, 513 as shown in FIG. 20A, and a clip 510. The barrel 503 alsodefines an inner lumen 520 and two or more window openings 512,521. Thebarrel 503 preferably comprises two half barrel pieces 514,515 securedto one another. The half barrel pieces 514,515 may be identical ingeometry.

The barrel 503, which may be formed by securing the two half barrelpieces 514, 515 together, defines an inner lumen 520 that extends alongan axis A of the guide 502, and two or more channels 509, 513 diagonalto the axis A. Each channel 509, 513 is in communication with acorresponding window opening 512, 521 located adjacent to the distal end582. Ultrasonic welding, adhesive bonding, snap leg features, or a clip510, or a number of other means may be used to secure the half barrelpieces 514, 515 together. The two channels 509, 513 preferably formed bythe construct of the barrel half pieces 514,515, are disposed within thebarrel 503 to guide the suture passing needle 501 through the tissue tobe sutured. The shaft section 506 of the monolithic snare 504 may beslidably disposed within the inner lumen 520 of the barrel 503 toprovide actuation of the suture snare loops 507. The snare loops 507 maytraverse within and extend laterally from the window openings 512,521.

The tips 516 of the snare loops 507 may serve as a landmark indicator,which is used to position the guide 502 against the internal peritonealwall. The two suture snare loops 507 serve the purpose of capturing thesuture material after it has been passed through the tissue wall. Theactuator section 505 of the monolithic snare 504 and tabs 508 of thebarrel 503 may facilitate the ease of handling of the guide 502. Eachsnare loop 507 preferably comprises a pre-formed shape with memorycharacteristics such that the snare loop 507 consistently takes on thesame shape whenever fully expanded.

As the actuator section 505 and shaft section 506 translate with respectto the barrel 503, the suture snare loops 507 move between two positionsof radially extended shown in FIGS. 19A and 19B and retracted shown inFIG. 21A. When each snare loop 507 is in the radially extendedconfiguration, a pre-defined loop, ring, circle or hoop shape preferablyextends laterally from the barrel 503. In the preferred embodiment, eachsnare loop 507 provides a corresponding C-shaped region 511 (from a sideview as shown in FIG. 22A) for a suture passing needle to pass into anddrop off the suture.

Each region 511 is concave with respect to the proximal end 581 of theguide 502. In the preferred embodiment, each snare loop 507 is alignedwith a corresponding tab 508 located directly above. Each snare loop 507defines an opening through which the carried suture traverses. In thepreferred embodiment having a pair of snare loops 507, each snare loop507 is preferably spaced 180 degrees apart from the other and disposeddistally adjacent to a corresponding channel exit point 518.

When the carried suture is released from the suture engaging device, thesuture section intersecting the opening of the snare loop 507 residesloosely until the snare loop 507 is retracted. When the snare loop 507is retracted, the suture material becomes trapped between the snare loop507 and the wall of the barrel 503 at the window opening 512 in thebarrel (see, e.g., FIG. 13C). In this retracted position, the actuatorsection 505 is pulled away from the barrel as shown in FIG. 21A. Theprojecting snares loops 507 are collapsed as they are withdrawn into thewindow opening 512 and further into the inner lumen 520 of the barrel503. The projecting sections of each snare loop 507 converge at thedistal end to form a rigid tip 516 that points upwardly and outwardlyfrom the barrel 503. The window opening 512 provides a recess forhousing the tip 513 to allow the tip 516 from protruding outside thebarrel 503 outer profile when in the retracted position, thus enablingsmooth entry of the guide when being placed through the tissue track. Asshown in FIG. 21b , the window opening 512 decreases in size as itextends towards the inner lumen 520. The snare tip 516 has an enlargedsize or width that acts as a positive stop in combination with thenarrowing window opening 512 to prevent excess proximal travel (i.e.,retraction) of the monolithic snare 504 within the barrel 503.

The monolithic snare 504 may be constructed from a polymer that canwithstand a high degree of strain. The percent of elongation at yieldmay range from 3-8%. The snare loop 507 may have thin cross-sections toprovide the flexibility to easily bend and conform to various geometricshapes yet stiff enough to create a self-supported snare loop thatextends generally perpendicular to the long axis of the guide. Themonolithic snare 504 may also extend laterally in a geometry that from aside view is a continuous radius 525 as shown in FIG. 22A. Thecontinuous radius 525 effectively keeps the rigid tip along the“continuous radius” path as the snare loop 507 is being retracted intothe barrel. The ratio of the continuous radius 525 to the crosssectional geometry of the snare loop 507 is such that the strain levelof the material when retracted and constrained in the barrel 503 willnot cause noticeable permanent deformation of the memorized pre-formedshape when constrained for a duration up to one hour. The same principleis true for the snare radii 526, 527, 528 as shown in the top planarview illustrated in FIG. 22B. Materials that may be used to constructthe monolithic snare 504 include plastics such as nylon, polyethylene,polyester or polypropylene.

In this alternative embodiment, the guide 502 provides two different,diagonal pathways for a suture passing needle apparatus and thuscomprises first and second channels 509, 513 as more clearly shown inFIG. 20A. The channels 509, 513 are directionally diagonal to the longaxis A of the guide 502 at some acute angle, preferably in the range of5-30 degrees. The angle of the channels 509, 513 controls the depth ofbite into the tissue, such that a greater angle provides a greater biteof tissue. Angular spacing between entries to the channels 509, 513 arepreferably equal (i.e., equiangular) depending upon the number ofchannels, e.g., 180 degrees apart if there are two channels, 120 degreesapart if there are three channels, etc. Therefore, channel exits arealso preferably equiangular. Two separate entry points 521, 522 areprovided on the channels 509, 513 for a suture passing needle to enterthe guide 502, as well as two separate exit points 518,523. Each channel509, 513, has a corresponding slot 512,524, or opening that allows for astrand of suture to be removed from the channel. This may be necessaryto complete the suture loop in the tissue. As shown in FIGS. 20A-B, theproximal section of each channel 509, 513, may have a wider mouthincluding a tapered section 517 that enables angulation of the suturepassing needle 501, such that a lesser angle allows a lesser bite oftissue.

The actuation section 505 of the monolithic snare 504 may have a lockingleg 519 that snap fits into a latch 529 in the barrel 503 as shown inFIG. 23. The locking leg 519 can be depressed to flex from the “locked”position to enable movement of the monolithic snare 504. The actuationsection 505 may also include a variety of other connectors to facilitatea releasable locking connection between the monolithic snare 504 and thebarrel 503.

In another embodiment shown in FIG. 24, the guide 530 comprises a barrel531 with indicia and a monolithic snare 532 with a ring-shaped actuationsection 533 for easy manipulation of the monolithic snare 532. The guide530 includes two indicators to facilitate deployment; 1) a line mark 535on an outer barrel surface 583, and 2) a lateral tip 536 of each snareloops 534. The two indicators can be employed in a method to accommodateproper positioning of the guide 530 in various abdominal wallthicknesses to achieve predictable suture placement in the tissue.

In the case of a laparoscopic surgery involving use of a trocar, theguide 530 may be placed through the tissue layers of the open trocarwound site as shown in FIGS. 25A and 25B to properly position the guide530 within the body cavity for receiving suture carried by one or moresuture engaging devices. This tissue track in the abdominal wall mayinclude skin 537, adipose tissue 538, muscle and fascia 539 and theperitoneum 540. Prior to insertion of the guide 530 through the tissuetrack, the actuator section 533 may be pulled away from the barrel 530in a proximal direction, moving the snare loops 534 into the fullyretracted position to achieve the most slender profile. Once the distalend of the guide 530 is appropriately placed posterior to the peritoneallayer 540, the actuator section 533 may be pushed toward the barrel 531,extending the suture snare loops 534 to inhibit the guide 530 fromexiting the body cavity. The guide 530 may then be retracted, ortranslated in a proximal direction away from the body cavity, until thelateral tips 536 are resting against the inner peritoneal wall 540 toposition the extended snare loops 534 for receiving suture carried bythe suture engaging device and to align the channels with theappropriate layers of tissue to be sutured, as shown in FIG. 25 a.

For patients with a relatively greater abdominal wall thickness,proximally translating the guide 530 until the expanded snare loops abutthe inner peritoneal wall 540 will concurrently position both channelexits beneath the skin surface 537.

Once the guide 530 is positioned with the peritoneal wall 540 andinhibited from exiting the body cavity by the extended suture snareloops 534, the suture engaging device 501, with a first free end section542 of suture 542 engaged, may be inserted through a first channel 544while carrying the first section 542 of suture 541, as shown in FIG.25A. Once the needle 551 exits the channel 544 it passes through variouslayers of tissue 539, 540, and enters the body cavity 570. As it entersthe body cavity 570, the needle 551 passes through the first snare loop534. The needle 551 may release the strand of suture 541 and be removedfrom the body leaving the suture section 542 loosely inside the expandedfirst snare loop 534. Thus, the suture section 542 is carried into thebody cavity to a point where the suture section 542 intersects andtraverses the generally planar opening defined by the expanded firstsnare loop 534.

The second free end section of suture 541 may then be engaged by thesame suture engaging device 501 or a second engaging device and insertedthrough the opposing second channel to place the second end suturesection 543. Once the needle 551 exits the opposing second channel itpasses through various layers of tissue 539, 540 and enters the bodycavity 570. As it enters the body cavity 570, the needle 551 passesthrough the opposing second snare loop 534. The needle 551 may releasethe second strand of suture 541 and be removed from the body leaving thesuture sections 542, 543 within the boundaries of the respective snareloops 534.

Moving the actuator section 533 away from the barrel retracts the snareloops 534 so as to capture the suture sections 542, 543. With bothsuture sections 542, 543 captured, the guide 530 is retracted from thetissue track, carrying the suture sections 542, 543. With the guide 530and suture sections 542, 543 exposed outside the body cavity, theactuator section 533 can be pushed toward the barrel 531 extending thesuture snare loops 534, and thus releasing the suture sections 542, 543.A knot can then be tied in the suture sections 542, 543 and secured toprovide closure of the wound.

FIG. 25B shows the placement of the needle 501 piercing through thetissue. The distance 545 from the puncture location of the needle 501through the peritoneum 540 to the closest edge, or perimeter, of thedefect, which coincides with the sidewall of the barrel, is desirable tobe nominally 8 mm. With the guide 530 positioned perpendicular to theskin surface and the lateral tips 536 resting against the innerperitoneal wall 540, the channels 544 are aligned to guide the needle551 through the desirable amount of tissue to be sutured. However, forthis method, the abdominal wall thickness 546 must be at an adequatethickness to assure the needle 551 will exit the channel 544 below theouter skin surface, or simply skin, 537 surrounding the body cavity. Itis undesirable to have the suture 541 through the skin 537.

FIG. 26 shows an abdominal wall thickness 547, where for the abovedescribed method of positioning the lateral tips 536 resting against theperitoneal wall 540 with the guide perpendicular to the skin surface,the thickness is not adequate. The needle is shown with a puncture 548through the skin 537 because the channel exits are positioned above oroutside the skin 537. The guide 530 needs to be inserted further intothe wound for the needle 551 to avoid piercing the skin 537—namely, forthe needle 551 to exit the channel exits of the guide 530subcutaneously. An indicator in the form of a line mark 535 is providedon the outer surface of the barrel 531 as a reference. When the linemark 535 is positioned below the skin surface 537, the exit of each ofthe first channel 544 (shown) and second channel (not shown) will bebelow the outer skin surface 537 such that the needle 551 will notpierce through the skin 537. FIG. 27A shows the guide 530 insertedfurther in the wound, where the line mark 535 is below the skin surface537 and thus no longer visible, such that both channel exits arepositioned beneath the outer skin surface 537. This results in thelateral tips 536 being a significant distance 548 away from theperitoneum 540, thereby properly positioning the guide 530 within thecavity. FIG. 27B shows the placement of the needle 501 piercing throughthe tissue. The relatively shorter distance 545 from the puncturelocation of the needle 501 through the peritoneum 549 to the edge of thedefect, which coincides with the sidewall of the barrel, may not bedesirable in such thinner abdominal walls.

An alternative indicator could be a recess or protrusion along the outerguide surface to provide a tactile feedback when the guide is translatedto a position where the recess or protrusion engages the skin. FIG. 31shows a preferred embodiment of the guide 530 with a proper depthindicator 584 comprising a recess 584. The recess 584 may be formedpartially about the circumference of the barrel surface 583.Furthermore, the edge of the recess may have a radius 585 at one or bothends of the edge, as shown in FIG. 32. The radius 585 would facilitatethe penetration of the barrel 531 past the skin surface with a twistingmotion while applying translational force. The tactile feedback of therecess 584 abutting the skin informs the user the guide is positionedsuch that both channel exits are positioned beneath the outer skinsurface 537. An indicator feature, such as the extended lateral tips 536of the snare loops, may then be utilized to determine the guide positionrelative to the peritoneum 540, An alternative feature could be a markon the barrel body at a level equivalent to the lateral tips of thesnare. If greater guide depth is desired, the guide may be twisted whileapplying a translation force to penetrate the guide beyond the skinsurface.

An alternative method can be used to achieve a desirable placement ofthe needle 551 and suture 541 through the tissue. FIG. 28A shows theguide 530 positioned in a relatively thinner abdominal wall thickness547 as described above. FIG. 28B shows the line mark 535 below the skin537. FIG. 28c shows the lateral tip 536 a vertical distance 548 from theperitoneum 540. Prior to the placing the needle 551 though the tissue539, 540, the lateral tip 536 may be used as a landmark while tiltingthe guide 530 at an angle to the primary guide axis 560, until the firstlateral tip 536 comes in close proximity to or abuts the peritoneum 540,as shown in FIG. 29. The tissue area 562 will compress, and placement ofthe needle 551 will encompassed a greater amount of tissue 539, 540.

With the tilted guide 530 in position, the suture engaging device 501,with a first free end section 542 of suture 542 engaged, may be insertedthrough a first channel 544 while carrying the section 542 of suture541. Once the needle 551 exits the channel 544 it passes through thecompressed layers of tissue 539, 540, and enters the body cavity. As itenters the body cavity, the needle 551 passes through the first snareloop 534. The needle 551 may release the strand of suture 541 and beremoved from the body leaving the suture section 542 loosely inside theexpanded snare loop 534. Thus, the first suture section 542 is carriedinto the body cavity to a point where the first suture section 542intersects and traverses the generally planar opening defined by theexpanded snare loop 534.

The guide 530 is then tilted in the opposite direction, such that theopposite second lateral tip 536 of the second snare loop 534 comes inclose proximity to the peritoneum 540. With the tilted guide 530 inposition, the second free end section of suture 541 may then be engagedby the suture engaging device 501 and inserted through the opposingchannel to place the second end suture section 543. Once the needle 551exits the opposing channel it passes through the compressed layers oftissue 539, 540 and enters the body cavity. As it enters the bodycavity, the needle 551 passes through the opposing second snare loop534. The needle 551 may release the strand of suture 541 and be removedfrom the body leaving the suture sections 542, 543 within the boundariesof the respective snare loops 534.

By tilting the guide 530 such that the lateral tip 536 of each receivingsnare loop 534 comes into contact with the adjacent peritoneum 540, agreater and more desirable horizontal distance, or “bite,” is achievedbetween each puncture location of the needle 501 through the peritoneum540 to the closest edge of the defect coinciding with the sidewall ofthe barrel.

Moving the actuator section 533 away from the barrel retracts the snareloops 534 so as to capture the suture sections 542, 543. With bothsuture sections 542, 543 captured, the guide 530 is retracted from thetissue track, carrying the suture sections 542, 543. With the guide 530and suture sections 542, 543 exposed outside the body cavity, theactuator section 533 can be pushed toward the barrel 531 extending thesuture snare loops 534, and thus releasing the suture sections 542, 543.A knot can then be tied in the suture sections 542, 543 and secured toprovide closure of the wound.

FIG. 30 illustrates a preferred method 600 for closing a surgical woundusing suture. Step 610 comprises actuating a guide into a slenderconfiguration for insertion into a body cavity by retracting amonolithic snare. Step 620 comprises translating the monolithic snaredistally with respect to a barrel to deploy at least two suture snareloops so as to radially expand a securing mechanism against an internalwall of the body cavity. Step 620 comprises positioning both channelexits beneath the outer surface of the skin.

If a thinner abdominal wall is involved, then optional step 630 may beemployed by tilting the guide in a first direction to cause a distal tipof a first snare loop to approach or abut an inner peritoneal wall.

Step 640 comprises engaging a first section of suture with a sutureengaging device, inserting the suture engaging device into a firstchannel of a guide, releasing the first section of suture in the bodycavity and retracting the device from the first channel.

Again, if a thinner abdominal wall is involved, then optional step 650may be employed by tilting the guide in a second direction opposite thefirst direction to cause a distal tip of a second snare loop to approachor abut the inner peritoneal wall.

Step 660 comprises engaging a second section of suture with the sutureengaging device, inserting the suture engaging device into a secondchannel of the guide, releasing the second section of suture in the bodycavity at an equiangular spacing from the released first section ofsuture, and retracting the device from the second channel. In apreferred embodiment where only two snare loops are provided, then thechannel exits, and associated snare loops are positioned 180 degreesfrom each other.

Step 670 comprises actuating the monolithic snare to retract the snareloops and secure the first and second sections of suture while forming aslender configuration of the guide. Step 670 may simply involvetranslating the actuation section in a proximal direction with respectto the barrel.

Step 680 comprises retracting the guide in the slender configurationwith the captured suture from the body.

This method 600 may also comprise rotating the guide and repeating steps610 through 680 to form as many stich loops as desired.

Many alterations and modifications may be made by those having ordinaryskill in the art without departing from the spirit and scope of theinvention. Therefore, it must be understood that the illustratedembodiments have been set forth only for the purposes of examples andthat they should not be taken as limiting the invention as defined bythe following claims. For example, notwithstanding the fact that theelements of a claim are set forth below in a certain combination, itmust be expressly understood that the invention includes othercombinations of fewer, more or different ones of the disclosed elements.

The words used in this specification to describe the invention and itsvarious embodiments are to be understood not only in the sense of theircommonly defined meanings, but to include by special definition in thisspecification the generic structure, material or acts of which theyrepresent a single species.

The definitions of the words or elements of the following claims are,therefore, defined in this specification to not only include thecombination of elements which are literally set forth. In this sense itis therefore contemplated that an equivalent substitution of two or moreelements may be made for anyone of the elements in the claims below orthat a single element may be substituted for two or more elements in aclaim. Although elements may be described above as acting in certaincombinations and even initially claimed as such, it is to be expresslyunderstood that one or more elements from a claimed combination can insome cases be excised from the combination and that the claimedcombination may be directed to a subcombination or variation of asubcombination.

Insubstantial changes from the claimed subject matter as viewed by aperson with ordinary skill in the art, now known or later devised, areexpressly contemplated as being equivalently within the scope of theclaims. Therefore, obvious substitutions now or later known to one withordinary skill in the art are defined to be within the scope of thedefined elements. The claims are thus to be understood to include whatis specifically illustrated and described above, what is conceptuallyequivalent, what can be obviously substituted and also what incorporatesthe essential idea of the invention.

What is claimed is:
 1. A surgical guide device to be placed through atissue track, comprising: a barrel defining a first channel and a secondchannel, the first channel comprising a first exit for directing a firstsuture portion into a body cavity, the second channel comprising asecond exit for directing a second suture portion into the body cavity;a distal tip located distally to the barrel and comprising a distal tipwall; a first self-supporting suture catcher positioned adjacent to thefirst exit; a second self-supporting suture catcher positioned adjacentto the second exit; and an actuator coupled to the first and secondself-supporting suture catchers, the actuator being configured to movethe first and second self-supporting suture catchers in unison between aradially extended configuration and a retracted configuration, wherein,in the radially extended configuration, the first self-supporting suturecatcher defines a first unencumbered opening through which, if the firstsuture portion is passed out of the first exit into the body cavity, thefirst opening is disposed to permit the first suture portion tointersect the first opening and then resides loosely within the firstopening, wherein in the radially extended configuration, the secondself-supporting suture catcher defines a second unencumbered openingthrough which, if the second suture portion is passed out of the secondexit into the body cavity, the second opening is disposed to permit thesecond suture portion to intersect the second opening and then residesloosely within the second opening; the first and second self-supportingsuture catchers are apart from one another; and the firstself-supporting suture catcher and the second self-supporting suturecatcher extend radially outward and in opposite directions from thedistal tip.
 2. The device of claim 1, wherein, in the radially extendedconfiguration, the first self-supporting suture catcher does not embedthe first suture portion and the second self-supporting suture catcherdoes not embed the second suture portion, when the first and secondsuture portions are passed out of respective first and second exits intothe body cavity.
 3. The device of claim 1, wherein the firstself-supporting suture catcher and the second self-supporting suturecatcher are detached and separate from any sharp needles.
 4. The deviceof claim 1, wherein: the actuator moves proximally with respect to thebarrel to move the first and second self-supporting suture catchers inunison to the retracted configuration; and the actuator moves distallywith respect to the barrel to move the first and second self-supportingsuture catchers in unison to the radially extended configuration.
 5. Thedevice of claim 1, wherein the first self-supporting suture catcher andthe second self-supporting suture catcher extend radially outward and inopposite directions from the distal tip without the distal tip axiallyshortening with respect to the barrel when changing between theretracted configuration and the radially extended configuration.
 6. Thedevice of claim 1, wherein retraction of the first self-supportingsuture catcher and the second self-supporting suture catcher in unisoncloses the first opening and the second opening while simultaneouslycapturing the first suture portion and the second suture portion, whenthe first and second suture portions are passed out of respective firstand second exits into the body cavity.
 7. The device of claim 1,wherein: the first self-supporting suture catcher in the radiallyextended configuration forms the first opening with a first region intowhich a needle is operable to pass and drop the first suture portionsuch that the first suture portion resides loosely within the firstopening; and the second self-supporting suture catcher in the radiallyextended configuration provides the second opening with a second regionsufficiently large into which the needle is operable to pass and dropthe second suture portion such that the second suture portion residesloosely.
 8. The device of claim 1, wherein: the first self-supportingsuture catcher in the radially extended configuration forms the firstopening with a first region into which a first needle is operable topass and drop the first suture portion such that the first sutureportion resides loosely within the first opening; and the secondself-supporting suture catcher in the radially extended configurationprovides the second opening with a second region sufficiently large intowhich a second needle is operable to pass and drop the second sutureportion such that the second suture portion resides loosely.
 9. Thedevice of claim 1, wherein, in the radially extended configuration, twodistinct catchers extend from the distal tip of the barrel, the twocatchers forming the first and second self-supporting suture catchers.10. A surgical guide device to be placed through a tissue track,comprising: a barrel defining a first channel and a second channel, thefirst channel comprising a first exit for directing a first sutureportion into a body cavity, the second channel comprising a second exitfor directing a second suture portion into the body cavity; a distal tiplocated distally to the barrel and comprising a distal tip wall; a firstself-supporting suture catcher positioned adjacent to the first exit; asecond self-supporting suture catcher positioned adjacent to the secondexit; and an actuator coupled to the first and second self-supportingsuture catchers, the actuator being configured to move the first andsecond self-supporting suture catchers in unison between a radiallyextended configuration and a retracted configuration, wherein in theradially extended configuration, the first self-supporting suturecatcher defines a first opening through which, if the first sutureportion is passed out of the first exit into the body cavity, the firstopening is disposed to permit the first suture portion to reside looselyupon release; in the radially extended configuration, the secondself-supporting suture catcher defines a second opening through which,if the second suture portion is passed out of the second exit into thebody cavity, the second opening is disposed to permit the second sutureportion to reside loosely; in the radially extended configuration, whenthe surgical guide device is positioned through the tissue track, thebody cavity on a first side of the barrel has the first self-supportingsuture catcher and the body cavity on a second side of the barrel hasthe second self-supporting suture catcher; retraction of the first andsecond self-supporting suture catchers in unison simultaneously capturesthe first and second suture portions by trapping the first and secondsuture portions without rotating the first and second self-supportingsuture catchers, when the first and second suture portions are passedout of respective first and second exits into the body cavity; the firstand second self-supporting suture catchers are apart from each other;and the first self-supporting suture catcher and the secondself-supporting suture catcher extend radially outward and in oppositedirections from the distal tip.
 11. The device of claim 10, wherein thefirst self-supporting suture catcher and the second self-supportingsuture catcher are detached and separate from any sharp needles.
 12. Thedevice of claim 10, wherein: the actuator moves proximally with respectto the barrel to move the first and second self-supporting suturecatchers in unison to the retracted configuration; and the actuatormoves distally with respect to the barrel to move the first and secondself-supporting suture catchers in unison to the radially extendedconfiguration.
 13. The device of claim 10, wherein the firstself-supporting suture catcher and the second self-supporting suturecatcher extend radially outward and in opposite directions from thedistal tip without the distal tip axially shortening with respect to thebarrel when changing between the retracted configuration and theradially extended configuration.
 14. The device of claim 10, whereinretraction of the first self-supporting suture catcher and the secondself-supporting suture catcher in unison closes the first opening andthe second opening while simultaneously capturing the first sutureportion and the second suture portion, when the first and second sutureportions are passed out of respective first and second exits into thebody cavity.
 15. The device of claim 10, wherein, in the radiallyextended configuration, two distinct catchers extend from the distal tipof the barrel, the two catchers forming the first and secondself-supporting suture catchers.
 16. A surgical guide device to beplaced through a tissue track, comprising: a needle for passing suture;a barrel defining a first channel and a second channel, the firstchannel comprising a first exit for directing a first suture portioninto a body cavity, the second channel comprising a second exit fordirecting a second suture portion into the body cavity; a firstself-supporting suture catcher positioned adjacent to the first exit; asecond self-supporting suture catcher positioned adjacent to the secondexit; a distal tip located distally to the barrel and comprising adistal tip wall; and an actuator coupled to the first and secondself-supporting suture catchers, where the first and second suturecatchers extend from the actuator, the actuator being configured to movethe first and second self-supporting suture catchers in unison between aradially extended configuration and a retracted configuration, wherein,in the radially extended configuration, the first self-supporting suturecatcher defines a first opening, wherein in the radially extendedconfiguration, the second self-supporting suture catcher defines asecond opening through which, if the second suture portion is passed outof the second exit into the body cavity, the second opening is disposedto permit the second suture portion to reside loosely within the secondopening; the first and second self-supporting suture catchers are apartfrom each other; and the first self-supporting suture catcher and thesecond self-supporting suture catcher exit radially outward and inopposite directions from the distal tip.
 17. The device of claim 16,wherein the first self-supporting suture catcher and the secondself-supporting suture catcher are detached and separate from any sharpneedles.
 18. The device of claim 16, wherein: the actuator movesproximally with respect to the barrel to move the first and secondself-supporting suture catchers in unison to the retractedconfiguration; and the actuator moves distally with respect to thebarrel to move the first and second self-supporting suture catchers inunison to the radially extended configuration.
 19. The device of claim16, wherein the first self-supporting suture catcher and the secondself-supporting suture catcher exit radially outward and in oppositedirections from the distal tip without the distal tip axially shorteningwith respect to the barrel when changing between the retractedconfiguration and the radially extended configuration.
 20. The device ofclaim 16, wherein retraction of the first self-supporting suture catcherand the second self-supporting suture catcher in unison closes the firstopening and the second opening while simultaneously capturing the firstsuture portion and the second suture portion, when the first and secondsuture portions are passed out of respective first and second exits intothe body cavity.